Cleared Traditional

COUNT-10 SYSTEM FOR STAND. URINALYSIS

K823364 · V-Tech, Inc. · Chemistry
Dec 1982
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K823364 is an FDA 510(k) clearance for the COUNT-10 SYSTEM FOR STAND. URINALYSIS, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by V-Tech, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982, 36 days after receiving the submission on November 9, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K823364 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1982
Decision Date December 15, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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